Dietary Intervention for Type 2 Diabetes
(DECIDE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Disqualifiers: Heart disease, Liver disease, Kidney disease, Cancer, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar.
Exciting new research indicates that "remission" of type 2 diabetes - defined as returning blood sugar into the normal range without having to use medications - through therapeutic nutrition may be possible for many people living with the condition.
We will examine the preference, adherence and clinical results of a low-calorie diet or low-carbohydrate diet in type 2 diabetes remission rates.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the dietary treatment for Type 2 Diabetes?
Research shows that low-calorie and low-carbohydrate diets can improve blood sugar control in people with Type 2 Diabetes, with some reports of remission. Very low-calorie diets are effective for initial weight loss and improving blood sugar levels, although long-term results may vary.
12345Is the dietary intervention for Type 2 Diabetes safe for humans?
Research indicates that low-calorie and low-carbohydrate diets, including very low-calorie diets, are generally safe for people with Type 2 Diabetes, though concerns about safety remain. These diets have been shown to help with weight loss and improve health markers, but it's important to discuss any dietary changes with a healthcare provider.
26789How does the low-calorie or low-carbohydrate diet treatment for type 2 diabetes differ from other treatments?
This treatment is unique because it focuses on dietary changes, specifically low-calorie or low-carbohydrate diets, which can lead to improved blood sugar control and even remission of type 2 diabetes in some patients. Unlike standard treatments that often rely on medication, this approach emphasizes nutrition and lifestyle changes, potentially reducing the need for diabetes medications.
2581011Eligibility Criteria
This trial is for adults aged 20-80 with Type 2 Diabetes, an HbA1c level of at least 6.0%, and a BMI over 27 kg/m2. Participants should be able to follow a low-calorie or low-carbohydrate diet without dietary restrictions and must have internet access. Those who've recently lost weight, had bariatric surgery, severe mental health issues, recent serious illnesses like cancer or heart disease, eating disorders, or are pregnant can't join.Inclusion Criteria
Your HbA1c level is 6.0% or higher.
You weigh more than what is considered healthy for your height.
I am between 20 and 80 years old.
+2 more
Exclusion Criteria
I have lost 5% or more of my weight in the past 6 months.
I have a history of liver disease.
You have food allergies or dietary restrictions that would make it hard for you to follow the diet plan.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1: Weight Loss and Medication Deprescribing
Participants undergo a weight loss program and medication deprescribing
12 weeks
In-person and virtual appointments
Phase 2: Transition to Sustainable Dietary Pattern
Participants transition to an individualized sustainable dietary pattern
8 weeks
Virtual visits
Phase 3: Weight Loss/Remission Maintenance
Participants maintain weight loss and diabetes remission
32 weeks
In-person and virtual appointments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study explores whether Type 2 Diabetes can go into remission through diet alone—without medications. It compares the effectiveness of a low-calorie diet versus a low-carbohydrate diet on lowering blood sugar levels to normal ranges.
2Treatment groups
Experimental Treatment
Group I: Low-carbohydrate diet groupExperimental Treatment1 Intervention
The low-carbohydrate diet will involve an individualized whole-food diet (30-130 grams carbohydrate per day) led through virtual visits with a registered dietitian.
Group II: Low-calorie diet groupExperimental Treatment1 Intervention
A low-calorie diet involving will involve a commercial weight loss program (pre-packaged foods from Ideal Protein, select lean protein sources, non-starchy vegetables) and be led by the pharmacist and registered dietitian (RD) involving in-person and virtual appointments.
Low-calorie diet or low-carbohydrate diet is already approved in European Union, United Kingdom, United States for the following indications:
🇪🇺 Approved in European Union as Therapeutic Nutrition for:
- Type 2 Diabetes Remission
🇬🇧 Approved in United Kingdom as Low-Calorie Diet for:
- Type 2 Diabetes Remission
🇺🇸 Approved in United States as Low-Carbohydrate Diet for:
- Type 2 Diabetes Management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of British Columbia OkanaganKelowna, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
[Why does nutrition therapy so often fail in non-insulin-dependent diabetes? What measures bring success?]. [2015]It is a common belief among physicians that nutritional therapy in type II diabetic subjects is inefficient because the patients do not comply with the recommendations. Failure of a therapeutic response leads to feelings of guilt in patients, followed by frustration, and refusal of further treatment. The physician rapidly starts with drug or insulin therapy before the effects of diet treatment are assessable. Nutritional recommendations for diabetics are basically the same as for non-diabetics. Successful dietary treatment of obese type II diabetic subjects requires realistic goals regarding weight loss. Frequent mistakes are that an ideal body weight is aimed for, and that the patients are asked to omit only carbohydrates in the diet. Splitting of the meals, and distribution of carbohydrate-containing foods to individual meals during the day are important components of a meal plan. The patient should also be counciled how to avoid visible and invisible dietary fats. Exchange lists are frequently administered, but they fail, because they are too complicated. Only a part of decompensated type II diabetic subjects respond to weight loss. The response is evident already after a few [2.3 kg] weight loss. Other diabetic subjects fail to improve their glucose control after weight loss. These patients require an alternative treatment, i.e. oral antidiabetic agents or insulin. Frequently behavior therapy is of advantage in obese type II diabetic subjects, in addition to longterm dietary treatment. Dieticians should be involved in all difficult cases since they have the necessary experience to perform this longterm treatment.
Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses. [2022]To explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes.
Prioritizing diabetes nutrition recommendations based on evidence. [2015]Recommendations for carbohydrate, protein, dietary fat, micronutrients, and alcohol are classified according the level of available evidence based on the American Diabetes Association evidence grading system. The grading of recommendations can be used to prioritize nutrition care as those graded A are the most robust and can be emphasized first. Strong evidence suggests that the total amount of carbohydrate in meals (or snacks) is more important than the source or type. All persons with diabetes can benefit from basic information concerning carbohydrate foods, portion sizes, and amounts to select for meals. Patients on intensive (physiological) insulin therapy or insulin pumps can adjust their bolus insulin according to the amount of carbohydrate they plan to ingest. Therefore, the first priority is to identify a food/meal plan that can be used to integrate an insulin regimen into the person's lifestyle. Nutrition therapy for type 2 diabetes progresses from prevention of obesity or weight gain to improving insulin resistance to contributing to improved metabolic control. Research supports nutrition therapy as an effective therapy in reaching treatment goals for glycemia, lipids, and blood pressure. Monitoring of outcomes is essential to assess the outcomes of lifestyle interventions and/or to determine if changes in medication(s) are necessary.
Dietary treatment and long-term weight loss and maintenance in type 2 diabetes. [2016]Increasing body weight, particularly abdominal weight, is associated with increasing risk for type 2 diabetes, and 80% of people with type 2 diabetes are overweight or obese. Weight loss and maintenance are challenging in the obese population without diabetes, and data suggest that this may be more difficult in obese people with diabetes. Various weight-loss strategies with follow-up for at least 1 year have been evaluated in people with diabetes with mixed results. Diet is most effective in promoting initial weight loss. Energy restriction will improve glycemic control within days of initiation, independent of weight loss. There is deterioration of the effects of dietary therapy on glycemic control over time, even with partial weight maintenance, because of the relaxation of energy restriction. Diet composition has little effect on glycemic control independent of total calories. Very-low-calorie diets lead to better initial weight loss and glycemic control but yield no better long-term results than more moderate treatment. The initial results from studies using prepared meals and liquid meal replacements show that weight loss and glycemic control are comparable with conventional dietary treatment. Comprehensive lifestyle therapies, involving diet, exercise, and behavioral modification, can lead to weight losses of approximately 2 to 10 kg over 10 to 20 weeks, with regain over 1 year of one-third to one-half of weight initially lost. The net improvement on glycemic control is usually small 1 year after weight loss. Creative strategies using these and other modalities are needed to improve long-term weight loss, weight maintenance, and glycemic control in patients with type 2 diabetes. Greater efforts in primary prevention are also needed because of the increasing prevalence of obesity and type 2 diabetes.
Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial. [2022]Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting.
Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. [2022]Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients.
Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. [2023]A very-low-calorie diet (VLCD) can reverse the underlying defects of type 2 diabetes mellitus (DM) in obese subjects. We determined the efficacy, safety, and durability of VLCD in Thai patients with DM and obesity.
The effects of partial use of formula diet on weight reduction and metabolic variables in obese type 2 diabetic patients--multicenter trial. [2022]To clarify the usefulness of protein-sparing modified formula diet in obese type 2 diabetic patients, the effects of partial use of formula diet on weight reduction and changes in related metabolic variables, and the improving rates of risk factors per 1% body weight reduction, were compared with those of conventional subcaloric diet.
Low-carbohydrate diet in diabetes mellitus treatment. [2019]There has been an increasing amount of information about the positive results of low-carbohydrate diet in the treatment of diabetes, pre-diabetes, metabolic syndrome and obesity in the form of randomized trials, their meta-analysis and case studies. Many of these indicate that low carbohydrate diets are safe, could significantly improve the compensation of both types of diabetes and the overall health of the diabetic patients. In successful therapy, this diet leads to weight loss, lower medication doses or prescribing, and in some cases of type 2 diabetes also to remission. However, the low carbohydrate diet is not recognized in Czech diabetology, and concerns remain particularly about its safety. This article is a summary of the current knowledge about low-carbohydrate diet, its benefits, risks and contraindications, and aims to initiate a discussion about its use as one of the options for dietary treatment of diabetics. Key words: diabetes mellitus - ketogenic diet - low-carbohydrate diet - metabolic syndrome - obesity.
Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]Nutrition therapy plays an integral role in the prevention and management of patients with type 2 diabetes (T2D). A potential strategy is the utilization of diabetes-specific nutrition formulas (DSNFs) as meal replacements. In this article, we distinguish DSNFs from standard nutrition formulas, review the clinical data examining the effectiveness of DSNFs, and propose an evidence-based algorithm for incorporating DSNFs as part of nutrition therapy in T2D. DSNFs contain slowly-digestible carbohydrates, healthy fats (e.g., monounsaturated fatty acids), and specific micronutrients, which provide added benefits over standard nutrition formulas. In short- and long-term clinical trials, DSNFs demonstrate improvements in postprandial glycemic responses translating into sustainable benefits in long-term glycemic control (e.g., hemoglobin A1c and glycemic variability) and various cardiometabolic outcomes. To facilitate the delivery of DSNFs in a clinical setting, the transcultural diabetes nutrition algorithm can be utilized based on body weight (underweight, normal weight, or overweight) and level of glycemic control (controlled or uncontrolled).
Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes. [2022]Obesity-related type 2 diabetes represents one of the most difficult challenges for the healthcare system. This retrospective study aims to determine the efficacy, safety and durability of a very-low-calorie ketogenic diet (VLCKD), compared to a standard low-calorie diet (LCD) on weight-loss, glycemic management, eating behavior and quality of life in patients with type 2 diabetes (T2DM) and obesity. Thirty patients with obesity and T2DM, aged between 35 and 75 years, who met the inclusion criteria and accepted to adhere to a VLCKD or a LCD nutritional program, were consecutively selected from our electronic database. Fifteen patients followed a structured VLCKD protocol, fifteen followed a classical LCD. At the beginning of the nutritional protocol, all patients were asked to stop any antidiabetic medications, with the exception of metformin. Data were collected at baseline and after 3 (T1) and 12 (T2) months. At T1 and T2, BMI was significantly reduced in the VLCKD group (p < 0.001), whereas it remained substantially unchanged in the LCD group. HbA1c was significantly reduced in the VLCKD group (p = 0.002), whereas a slight, although not significant, decrease was observed in the LCD group. Quality of life and eating behavior scores were improved in the VLCKD group, whereas no significant changes were reported in the LCD group, both at T1 and T2. At the end of the study, in the VLCKD group 26.6% of patients had stopped all antidiabetic medications, and 73.3% were taking only metformin, whereas 46.6% of LCD patients had to increase antidiabetic medications. The study confirms a valuable therapeutic effect of VLCKD in the long-term management of obesity and T2DM and its potential contribution to remission of the disease.